Recombinant alpha-1-antitrypsin gel studied for the treatment of atopic dermatitis

Journal of Drugs in Dermatology, Jan-Feb, 2004

ProMetic Life Sciences and Arriva Pharmaceuticals have announced that their joint venture company, Arriva-ProMetic, has opened a Phase II clinical study to evaluate its lead candidate recombinant alpha 1-antitrypsin (rAAT) topical gel in individuals with atopic dermatitis. The phase II study will evaluate the safety and efficacy of AP-102 gel containing rAAT, in subjects afflicted with atopic dermatitis.

The study will be conducted in four centers in Canada. The study is designed to demonstrate the efficacy of the recombinant version compared to the positive clinical effect of plasma-derived AAT. The current supply of natural plasma-derived AAT, however, is only available in limited quantities. Arriva-ProMetic has developed recombinant alpha 1-antitrypsin as a cost-effective alternative to steroid therapy. An open-label pilot study with the approved plasma-derived AAT product demonstrated positive results in the treatment of several dermatological diseases including atopic dermatitis and psoriasis. In this study, AAT stopped pain and itching and promoted tissue healing without scarring.